On December 26th, the "2025 Overall Pharmaceutical CMC Research Strategy National Tour Salon - API Overseas Expansion Strategy Series" event was successfully held in Nanjing. This event was hosted by MilestonePharma and co-organized by Glodom Technology Co., Ltd. The strong alliance between MilestonePharma and Glodom has jointly built an industry exchange platform, promoting the process of Chinese pharmaceutical APIs going global.

The event adopted a combination of offline closed-door meetings and online live broadcasts, attracting nearly many industry experts and representative enterprises from the upstream and downstream industrial chains. Everyone jointly discussed the overall research strategy of pharmaceutical CMC, offered suggestions for API overseas expansion, promoted the Chinese pharmaceutical industry to explore new development paths, and helped Chinese drugs achieve high-quality development globally.

In the current complex and ever-changing global environment, "going global" has become a hot topic in the pharmaceutical industry. This event invited many senior industry experts, aiming to analyze the challenges and opportunities faced by API overseas expansion, and share practical experience and innovative thinking models. Glodom and MilestonePharma, as active promoters in the industry, have always been committed to building a sharing platform, promoting knowledge exchange and innovative thinking collisions, and jointly contributing to the internationalization process of the Chinese pharmaceutical industry.

During the event, seven industry authoritative experts delivered wonderful speeches and discussions on the related strategies and technologies of API overseas expansion. They respectively started from multiple dimensions such as policies and regulations, market trends, and technological innovation, bringing profound insights and valuable suggestions to the participants. The specific topics included: a detailed elaboration of the key differences and compliance strategies in on-site inspections between China and the United States; the implementation and optimization of the QbD strategy in API process research and development; the differences in regulatory regulations for domestic and foreign API filings and the filing processes such as CEP/ASMF; an analysis of the systematic sterility assurance strategy in the global mainstream market; an interpretation of the regulatory requirements and technical challenges in the communication and exchange of innovative drugs between China and the United States; a discussion on the key role of drug polymorphism research in new drug development and generic drug quality control; and the latest progress and related cases of genotoxic and nitrosamine impurity regulations in the Chinese, American, and European pharmaceutical markets.

As an experienced language service provider and a powerful assistant for pharmaceutical companies in internationalization, Glodom conducted in-depth and professional discussions and analyses on several core challenges faced by pharmaceutical companies on the way overseas - the standard differences in on-site inspections between China and the United States, the effective application of the Quality by Design (QbD) strategy in API process research and development, and the international registration and filing processes of APIs, excipients, and packaging materials.

As a top 100 global and innovative language technology solution provider, Glodom has accumulated profound professional knowledge in fields such as life sciences, demonstrating its deep industry insights and technological innovation capabilities in multiple industries such as pharmaceutical internationalization. With its advanced technology platform and rich project management experience, Glodom has established long-term and stable cooperative relationships with many companies around the world, winning wide recognition and trust.

In the future, Glodom will continue to rely on its global language service network, advanced AI technology platform, and professional data processing capabilities, and join hands with more industry partners to jointly explore new paths and opportunities for API overseas expansion. Driven by technological innovation and aiming at win-win cooperation, Glodom will jointly write a new chapter in the internationalization of the Chinese pharmaceutical industry.